Fibromyalgia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who meet the American College of Rheumatology's official criteria for fibromyalgia, which includes having widespread pain in at least 4 out of 5 body regions, pain and symptom scores above certain thresholds, and symptoms that have been present at a similar level for at least 3 months.
• People who have tried at least two medications commonly used for fibromyalgia (such as pregabalin, duloxetine, or milnacipran) without enough benefit.
• People who have tried at least one form of physical or movement-based therapy for fibromyalgia without enough benefit — this covers a wide range of approaches including exercise programs, water therapy, yoga, massage, stretching, heat or cold therapy, mindfulness, cognitive-behavioural therapy, and others (confirm with trial site for the full list).
• People who rate their pain at 4 or higher out of 10 at both their screening appointment and their baseline appointment.
• People who are willing and able to follow all study procedures, not start new treatments during the study, and stay on the same mental health treatment plan from at least one month before screening through the main study period, unless a change is recommended or agreed to by the trial doctor.
• People who are capable of becoming pregnant must have a negative pregnancy test at screening and agree to use a highly effective form of contraception throughout the trial (such as an IUD, tubal ligation, vasectomised partner, or long-acting contraceptive).
• People who are willing and able to give informed consent to participate.

Who may not be able to join:

• People who have ever been diagnosed with bipolar disorder or a schizophrenia-spectrum disorder at any point in their lifetime.
• People who have been diagnosed with a moderate or severe alcohol or other substance use disorder within the past 6 months.
• People who have been diagnosed with obsessive compulsive disorder or post-traumatic stress disorder within the past 30 days, where that condition is considered unstable by the trial doctor.
• People who have had a primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder within the past 3 months.
• People who have a clinically significant neurodevelopmental, neurocognitive, or personality disorder (confirm with trial site for what this may include).
• People who are assessed as being at moderate or high risk of suicide, based on a standard screening tool called the Columbia-Suicide Severity Rating Scale, or in the judgement of the trial doctor.

Important: Always verify eligibility with the trial site directly before applying.